Incontinence treatment device with pubic arm attachment mechanism

ABSTRACT

An implant includes a support body defining a longitudinal axis, two transverse arms, two pubic arms, and a pubic arm attachment mechanism. The two transverse arms are aligned on a common transverse axis of the implant. The two pubic arms include a first pubic arm spaced a distance apart from a second pubic arm and both the first and second pubic arms are parallel to the longitudinal axis. The pubic arm attachment mechanism is attached to an end of each of the first and second pubic arms. Each of the first and second pubic arms has an arm length that is less than a body length of the support body.

BACKGROUND

Urinary incontinence is the undesired leakage of urine from the bladderand this malady affects both men and women, with some estimates as highas 30% of the population experiencing some level of urinaryincontinence.

Devices for treating urinary incontinence include slings, supports, andother devices that are implanted in a patient's body to support,elevate, or compress the urethra. A urethral support is a urinaryincontinence treatment device that is surgically implanted under theurethra to inhibit urine from undesirably exiting the urethra,particularly during a provocative event such as when coughing orsneezing.

Other urinary incontinence treatment devices include artificialsphincters that selectively coapt the urethra and injected bulkingliquids that are applied alongside a layer of the urethra to support orpartially coaptate the urethra.

Improved incontinence treatment methods and devices would be welcomed byboth the patient and the surgical staff.

SUMMARY

One aspect provides an implant adapted to treat urinary incontinence.The implant includes a support body defining a longitudinal axis, twotransverse arms, two pubic arms, and a pubic arm attachment mechanism.The two transverse arms include a first arm extending from the supportbody transverse to the longitudinal axis and a second arm extending fromthe support body in a direction opposite the first arm and transverse tothe longitudinal axis such that the first and second arms providetransverse arms that are aligned on a common transverse axis of theimplant. The two pubic arms include a first pubic arm extending from thesupport body and a second pubic arm extending from the support body,with the first pubic arm spaced a distance apart from the second pubicarm and both the first and second pubic arms parallel to thelongitudinal axis. The pubic arm attachment mechanism is attached to anend of each of the first and second pubic arms. The support body has abody length extending between a first edge of the implant that iscoincident with the transverse arms to a second edge of the implantlocated between the first and second pubic arms. Each of the first andsecond pubic arms has an arm length extending from the second edge ofthe implant to the end of the pubic arm and the arm length is less thanthe body length of the support body.

One aspect provides a method of treating urinary incontinence includingforming a first incision exposing urethral tissue, and inserting an armof a support into the first incision and penetrating an obturatorforamen with the arm of the support. The method includes inserting apubic arm of the support into the first incision without making aseparate incision for placement of the pubic arm. The methodadditionally includes fixating the pubic arm by securing a separatepubic arm attachment mechanism that is fixed to an end of the pubic armto tissue that is located lateral to the pubic symphysis.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a top view of one embodiment of an implant adapted to treaturinary incontinence including a pubic arm attachment mechanism attachedto each pubic arm.

FIG. 2 is a side view of the implant illustrated in FIG. 1.

FIG. 3 is a perspective schematic view of the implant illustrated inFIG. 1 implanted in a male patient.

FIG. 4 is a top view of one embodiment of an implant adapted to treaturinary incontinence including a pubic arm attachment mechanism attachedto each pubic arm.

FIG. 5 is a side view of the implant illustrated in FIG. 4.

FIG. 6 is a perspective schematic view of the implant illustrated inFIG. 4 implanted in a male patient.

FIG. 7 is a front view illustrating a location of a perineal incisionand a separate different location of a scrotal incision useful whenimplanting various embodiments of the implant described in thisspecification.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

People suffering from urinary incontinence have a diminished ability torestrict the flow of urine through the urethra, usually due to a damagedor deficient urethral sphincter. The urethral sphincter is a collectionof muscles that control the flow of urine from the bladder. Thesemuscles envelop the urethra, and when contracted, seal the urethra shut.In general terms, each person has two urethral sphincters: an internalsphincter muscle of the urethra and an external sphincter muscle of theurethra. The internal sphincter muscle of the urethra is located nearthe junction of the urethra and the bladder. The external sphinctermuscle of the urethra is located at the distal inferior end of thebladder in females and inferior to the prostate (at the level of themembranous urethra) in males.

The urethra is normally supported by connective and other tissues. Thesupport provided by the connective tissues to the urethra can erode overtime, giving rise to hyper-mobility of the urethra. Hyper-mobileurethras are susceptible to the undesirable leaking of urine duringprovocative events such as sneezing, laughing, or coughing (which issometimes referred to as stress urinary incontinence).

The implant described herein is adapted to treat urinary incontinenceand includes pubic arms that are shorter than a length of the supportbody of the implant. The shortened pubic arms each include an attachmentmechanism that allows the pubic arms to be placed/implanted/fixed to thepatient without making a separate incision for placement of the pubicarms. For example, pubic arms are typically placed by an instrument thatis inserted into the skin of the abdomen above the pubic bone, and theinstrument is tunneled anterior to the pubic bone in a “pre-pubic” or“supra-pubic” approach until the instrument exits an incision betweenthe anus and the penis. In contrast, the implant described in thisspecification allows the pubic arms to be implanted and fixed in placewithout forming a separate skin access site. The implant described inthis specification can be implanted through a single incision throughwhich the support and the arms of the implant are passed prior to fixingthe arms to tissue or other support structures.

FIG. 1 is a top view of one embodiment of an implant 20 adapted to treaturinary incontinence. The implant 20 includes a support body 22 defininga longitudinal axis L, two transverse arms 24, 26, two pubic arms 34,36, and a pubic arm attachment mechanism 44, 46, respectively, for eachpubic arm 34, 36.

The two transverse arms include a first arm 24 extending from thesupport body 22 transverse to the longitudinal axis L and a second arm26 extending from the support body 22 in a direction opposite the firstarm 24 and transverse to the longitudinal axis L such that the first andsecond arms 24, 26 provide transverse arms that are aligned on a commontransverse axis T of the implant.

The two pubic arms include a first pubic arm 34 extending from thesupport body 22 and a second pubic arm 36 extending from the supportbody 22, with the first pubic arm 34 spaced a distance apart from thesecond pubic arm 36 and both the first and second pubic arms orientedparallel to the longitudinal axis L.

The pubic arm attachment mechanisms 44, 46 are each attached to an endof a respective one of the first and second pubic arms 34, 36.

The support body 22 has a body length LB extending between a first edge50 of the implant 20 that is coincident with the transverse arms 24, 26to a second edge 52 of the implant located at a midpoint between thefirst and second pubic arms 34, 36. Each of the first and second pubicarms 34, 36 has an arm length LA extending from the second edge 52 ofthe implant 20 to the ends 54 of the pubic arms 34, 36. In oneembodiment, the arm length LA is less than the body length LB of thesupport body 22.

In one embodiment, the arms 24, 26 are provided as trans-obturator armsand each include an optional and removable insertion sheath 64, 66,respectively, and a suture 67 attached to the end of each arm 24, 26 andits respective insertion sheath 64, 66. During implantation of theimplant 20 an introducer tool is utilized to separately engage eachsuture 67 and sequentially pass the first and second arms 24, 26 througha respective one of the first and second obturator foramen of thepatient, as described below. The trans-obturator arms 24, 26 are passedthrough the obturator foramen of the patient, and the insertion sheaths64, 66 are provided to allow the arms 24, 26 to pass through the tissueof the obturator foramen in a way that reduces the curling of the edgesof the arms 24, 26. The insertion sheaths 64, 66 and the suture 67 areremovable from the arms 24, 26 after the implant 20 is implanted. Thesuture 67 is provided to permit the tool to guide the arms 24, 26 andthe insertion sheath 64, 66, respectively, when implanting the implant20.

In one embodiment, the implant 20 is provided as a synthetic suburethralsling configured to treat stress urinary incontinence and the supportbody 22 is fabricated from knitted, monofilament polypropylene. Thestructure of the implant 20 is configured to allow tissue in-growththrough at least a portion of the support body 22 or the arms 24, 26,34, 36.

In one embodiment, the support body 22 is porous (having a plurality ofpores or openings) and is fabricated from a knitted or woven or nonwovenmesh material. In one embodiment, the arms 24, 26 and 34, 36 areintegrally formed with the support body 22 such that the support body 22and the arms 24, 26 and 34, 36 are fabricated from a single unitarypiece of material. In one embodiment, the support body 22 and the arms24, 26 and 34, 36 are fabricated from a flexible knit mesh. In oneembodiment, this single unitary piece of material is a porous polymermesh. In one embodiment, the arms 24, 26 and 34, 36 are separatelyattached to the support body 22 and are fabricated from a material thatis different than the support body 22.

In one embodiment, the insertion sheaths 64, 66 are provided as smoothpolymer films and are fabricated in a flattened tubular structure and soconfigured to be removably placed over each of the arms 24, 26,respectively. The insertion sheaths 64, 66 are suitably fabricated froma polyolefin, such as polyethylene of polypropylene.

The sutures 67 are suitably selected from thermoplastic sutures,non-thermoplastic sutures, multi-filament sutures, or mono-filamentsutures. In one embodiment, the sutures 67 are polypropylene sutures.

FIG. 2 is a right side view of the implant 20. The sheath 66 is disposedover the arm 26 and the pubic arm attachment mechanism 46 is attached toan end of the pubic arm 36. FIG. 2 illustrates that the arm length LA ofthe pubic arm 36 is less than the body length LB of the support body 22.

In one embodiment, the pubic arm attachment mechanism 46 is provided asa separate plastic clip that is attached over the end of the pubic arm36 and is provided with at least one through-hole 70. In one embodiment,the clip is rigid and inflexible. In one embodiment, the clip isflexible and formed of a compliant material such as silicone, orsilicone rubber, or rubber, or a rubber-like material. With reference toFIG. 1, each of the pubic arm attachment mechanisms 44, 46 is providedwith three through-holes 70, although it is to be understood that thenumber of through-holes 70 can range from one through-hole to four ormore or several through-holes. The through-holes 70 are configured toreceive suture that allows the pubic arm attachment mechanisms 44, 46 tobe attached to tissue, for example periosteum tissue of the pubic bone.

In one embodiment, the pubic arm attachment mechanism 46 is injectionmolded over the end of the pubic arm 36. In one embodiment, the pubicarm attachment mechanism 46 is a clam-shaped clip that is attached tothe end of the pubic arm 36. The pubic arm attachment mechanism 46 maynot align exactly with the end of the pubic arm 36, however the lengthof the pubic arm 36 and the length of the pubic arm attachment mechanism46 combine to form a length that is less than the body length LB of thesupport body 22.

FIG. 3 is a perspective schematic view of the implant 20 implanted in amale patient. In general terms, a method of treating urinaryincontinence includes: forming a first incision exposing urethral tissueUT; inserting an arm 24 of a support 20 into the first incision andpenetrating an obturator foramen OF with the arm 24 of the support 20;inserting a pubic arm 34 of the support 20 into the first incisionwithout making a separate incision for placement of the pubic arm 34;and fixating the pubic arm 34 by securing a separate pubic armattachment mechanism 44 to tissue that is located lateral to the pubicsymphysis PS.

Specific aspects of one suitable surgical procedure are described in thefollowing paragraphs. The patient is typically placed in a dorsallithotomy position with the legs positioned at about 90 degrees and heldin place by stirrups. The patient is catheterized, for example with a 14French catheter. The surgeon makes a vertical perineal incision in themidline and dissects tissue to eventually isolate the ventral bulbousurethra and pubic rami R while ensuring that the bulbospongiosus musclearound the urethra is intact. The surgeon will subsequently expose thebulbospongiosus muscle and take it off the perineal body to allowventral urethral elevation compression by the support body 22.

The implant 20 is placed by engaging the suture 67 attached to each oneof the trans-obturator arms 24, 26 with a suitable introducer tool andpassing each of the arms 24, 26 through the perineal incision from themedial to the lateral through the obturator foramen in what has becomeknown as an “inside-out” maneuver.

In one embodiment, each of the trans-obturator arms 24, 26 isindividually introduced into the perineal incision by a curvedintroducer tool that directs each arm 24, 26 around the pubic ramus Runtil the suture 67 exits the perineal incision. In this manner, eacharm 24, 26 is wrapped around a respective pubic ramus and the suture 67enters and exits the perineal incision without forming a separate skinpuncture for placement of the arms 24, 26.

In one embodiment, each of the pubic arms 34, 36 is individuallyintroduced into the perineal incision and the pubic arm attachmentmechanism 44 is attached to tissue on a left lateral side of the pubicsymphysis PS and the pubic arm attachment mechanism 46 is attached totissue on a right lateral side of the pubic symphysis PS. In oneembodiment, the pubic arm attachment mechanisms 44, 46 are attached tothe periosteum tissue of the pubic bone PB. In this manner, the pubicarms 34, 36 are placed through a single incision (the one perinealincision) without forming a separate skin puncture for placement of thearms 34, 36. That is to say, embodiments provide placement of the entireimplant 20 through a single incision. The single incision may be aperineal incision as described above, or alternatively, the singleincision may be a scrotal incision as described below.

FIG. 4 is a top view and FIG. 5 is a right side view of one embodimentof an implant 100 adapted to treat urinary incontinence. The implant 100includes the support body 22 described above defining the longitudinalaxis L, the two transverse arms 24, 26 described above, two pubic arms104, 106, and a pubic arm attachment mechanism 114, 116 for each pubicarm 104, 106.

The two transverse arms 24, 26 extend from the support body 22transverse to the longitudinal axis L and are aligned on a commontransverse axis T of the implant.

The two pubic arms 104, 106 extend from the support body 22, with thefirst pubic arm 104 spaced a distance apart from the second pubic arm106 and both the first and second pubic arms oriented parallel to thelongitudinal axis L.

The pubic arm attachment mechanisms 114, 116 are each attached to an endof a respective one of the first and second pubic arms 104, 106. In oneembodiment, the pubic arm attachment mechanisms 114, 116 are provided asa plurality of pre-attached sutures stitched into an end of each of thepubic arms 104, 106. The stitching of the sutures of the attachmentmechanisms 114, 116 reinforce and strengthen the ends of the first andsecond pubic arms 104, 106.

The support body 22 has a body length LB extending between the firstedge 50 of the implant 100 that is coincident with the transverse arms24, 26 to a second edge 122 of the implant 100 located at a midpointbetween the first and second pubic arms 104, 106. Each of the first andsecond pubic arms 104, 106 has an arm length LA extending from thesecond edge 122 of the implant 100 to the ends 124 of the pubic arms104, 106. In one embodiment, the arm length LA is less than the bodylength LB of the support body 22. In one embodiment, the length of thepubic arms 104, 106 and the length of the pubic arm attachmentmechanisms 114, 116, respectively, combine to form a length that is lessthan the body length LB of the support body 22.

FIG. 6 is a perspective schematic view of the implant 100 implanted in amale patient. Implantation of the implant 100 is similar to theprocedure described above. The patient is typically placed in the dorsallithotomy position with the legs positioned at about 90 degrees and heldin place by stirrups. The patient is catheterized and the surgeon makesan incision, for example, a scrotal incision as illustrated. The surgeondissects tissue to eventually isolate the ventral bulbous urethra andpubic rami R while ensuring that the bulbospongiosus muscle around theurethra is intact. The surgeon will subsequently expose thebulbospongiosus muscle and take it off the perineal body to allowventral urethral elevation compression by the support body 22.

The implant 100 is placed by engaging the suture 67 attached to each oneof the trans-obturator arms 24, 26 to a suitable introducer and passingeach of the arms 24, 26 through the scrotal incision from the medial tothe lateral through the obturator foramen taking care to avoid all nervebundles.

In one embodiment, each of the trans-obturator arms 24, 26 isindividually introduced into the scrotal incision by a curved introducertool that directs each arm 24, 26 around the pubic ramus R until thesuture 67 exits the scrotal incision. In this manner, each arm 24, 26 iswrapped around a respective pubic ramus and the trans-obturator arms 24,26 are placed through the scrotal incision without forming a separateskin puncture for placement of the arms 24, 26.

In one embodiment, each of the pubic arms 104, 106 is individuallyintroduced into the scrotal incision and the sutures of the pubic armattachment mechanism 114 are attached to tissue on a left lateral sideof the pubic symphysis PS and the sutures of the pubic arm attachmentmechanism 116 are attached to tissue on a right lateral side of thepubic symphysis PS. In one embodiment, the pubic arm attachmentmechanisms 114, 116 are attached to the periosteum tissue of the pubicbone PB lateral to the pubic symphysis PS. In this manner, the pubicarms 104, 106 are placed through a single incision (the one scrotalincision) without forming a separate skin puncture for placement of thearms 104, 106. That is to say, embodiments provide placement of theentire implant 100 through a single incision. The single incision may bea perineal incision as described above in FIG. 3, or alternatively, thesingle incision may be a scrotal incision as described here in FIG. 6.

FIG. 7 illustrates a location for a scrotal incision and a separatelocation for a perineal incision. Embodiments of the implants describedabove are consistent with implantation through either a single scrotalincision or a single perineal incision.

Regarding the selection of the scrotal incision for implantation of animplant described above, the penis and the scrotum are moved cephaladand held in place by tape or a retractor. The scrotal incision is formedat the base of the scrotum laterally relative to the midline of thepatient.

Regarding the selection of the perineal incision for implantation of animplant described above, the penis and the scrotum are moved cephaladand the perineal incision is formed between the anus and the scrotum onthe midline of the patient.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. An implant adapted to treat urinary incontinence, the implantcomprising: a support body defining a longitudinal axis; a first armextending from the support body transverse to the longitudinal axis anda second arm extending from the support body in a direction opposite thefirst arm and transverse to the longitudinal axis such that the firstand second arms comprise transverse arms that are aligned on a commontransverse axis of the implant; and a first pubic arm extending from thesupport body and a second pubic arm extending from the support body, thefirst pubic arm spaced a distance apart from the second pubic arm andboth the first and second pubic arms parallel to the longitudinal axis;and a pubic arm attachment mechanism attached to an end of each of thefirst and second pubic arms; wherein the support body has a body lengthextending between a first edge of the implant that is coincident withthe transverse arms to a second edge of the implant located between thefirst and second pubic arms; and wherein each of the first and secondpubic arms has an arm length extending from the second edge of theimplant to the end of the pubic arm and the arm length is less than thebody length of the support body.
 2. The implant of claim 1, wherein thelength of the pubic arm and a length of the pubic arm attachmentmechanism combine to form a length that is less than the length of thesupport body.
 3. The implant of claim 1, wherein the support body andthe pubic arms are fabricated of a flexible knit mesh and the pubic armattachment mechanism is a clip formed to include at least onethrough-hole extending through the clip.
 4. The implant of claim 1,wherein the pubic arm attachment mechanism is a plurality ofpre-attached sutures stitched into the end of each of the pubic arms. 5.An implant adapted to treat urinary incontinence, the implantcomprising: a support having a longitudinal axis; transverse arms thatare aligned on a transverse axis of the implant transverse to thelongitudinal axis; a first pubic arm spaced a distance apart from asecond pubic arm and both the first and second pubic arms parallel tothe longitudinal axis; and an attachment mechanism attached to an end ofeach of the first and second pubic arms; wherein the support has a bodylength extending between a first edge of the implant that is coincidentwith the transverse arms to a second edge of the implant located betweenthe first and second pubic arms, and each of the first and second pubicarms has an arm length extending from the second edge of the implant tothe end of the pubic arm that is less than the body length of thesupport; wherein the transverse arms are each insertable through asingle incision into an obturator foramen of a pelvis and eachattachment mechanism is attachable to periosteum tissue through the samesingle incision to allow the implant to support tissue of the bulbarurethra.